DEVICE: FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM (05030267080731)

Device Identifier (DI) Information

FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM
2251000
In Commercial Distribution

Intersurgical Incorporated
05030267080731
GS1

1
785952607 *Terms of Use
FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM ADULT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
No
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57813 CPAP/BPAP face mask, single-use
A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZD Ventilator, Non-Continuous (Respirator)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121747 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d7d6c105-269e-47e1-b921-3c203db67210
February 11, 2025
3
October 06, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05030267089680 12 05030267080731 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
3154512900
support@intersurgicalinc.com
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